BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNICEL® DXC 600I SYNCHRON® ACCESS® CLINICAL SYSTEM

    MDR report key: 1897129 · Received November 11, 2010

    Report

    Report Number
    2050012-2010-01264
    Event Type
    Malfunction
    Date Received
    November 11, 2010
    Date of Event
    October 23, 2010
    Report Date
    November 11, 2010
    Manufacturer
    BECKMAN COULTER INC.
    Product Code
    JJE
    PMA / PMN Number
    K060256
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    QC WAS WITHIN THE LAB'S ESTABLISHED RANGES. A FIELD SERVICE ENGINEER (FSE) WENT ON-SITE, DECONTAMINATED THE ISE SYSTEM AND CHANGED THE RATIO PUMP PISTON. THE INSTRUMENT IS NOW PERFORMING WITHIN SPECIFICATIONS.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) STATING THAT THE FIRST REPLICATE OF A SODIUM (NA) RUN RECOVERS HIGH. IN A PRECISION RUN WITH 4 REPLICATES, THE NA RESULTS WERE 145MMOL/L, 139MMOL/L, 139MMOL/L AND 139MMOL/L. THE SAME SAMPLE RUN ON THE OTHER INSTRUMENT GAVE A NA RESULT OF 139MMOL/L. ANOTHER EXAMPLE WAS PROVIDED BY THE CUSTOMER. THE RESULTS WERE 151MMOL/L, 144MMOL/L, 143MMOL/L AND 144MMOL/L. NO ERRONEOUS RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNICEL® DXC 600I SYNCHRON® ACCESS® CLINICAL SYSTEM CLINICAL CHEMISTRY ANALYZER JJE BECKMAN COULTER INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1